Blood vessel occlusion trocar

ABSTRACT

Apparatus in the form of a trocar adapted for penetration of the wall of a blood vessel, such as the ascending aorta, contains an inflatable diaphragm carried in a collapsed condition within the interior of the trocar and an appropriate fluid connection of the diaphragm to a source of inflating fluid effects the expansion of the diaphragm and release from the trocar into occluding relation with the blood vessel wall to obstruct the flow of blood through the occluded passage. The interior of the described trocar is divided into separate fluid conducting passages which, via the provision of appropriately placed openings in the wall of the shell forming the trocar, enables the performance of a multitude of procedures attendant with cardiac surgery by way of a single incision made in the wall of the aorta, such procedures including aortic arterial perfusion in conjunction with heart-lung machine operation; admission of myocardial preservation solution; aortic root pressure measurement and venting and clearing of the heart and aortic root. The invention contemplates use with the apparatus of a pressurizing belt containing an expandable cuff whose operation is coincident with that of the occluder diaphragm to prevent distention of the blood vessel wall and the prospective dangerous conditions resulting therefrom.

This application is a division of application Ser. No. 07,808,767, filedDec. 17, 1991, now U.S. Pat. No. 5,339,498.

BACKGROUND OF THE INVENTION

This invention relates to cardiovascular surgical apparatus. Moreparticularly, the invention relates to apparatus, a principle functionof which is to more safely occlude the ascending aorta during theperformance of open-heart surgery.

In many surgical procedures it is necessary to occlude a blood vessel inorder to provide the surgeon with a bloodless field in which to work.Such occlusion is most commonly effected by the application of avascular clamp to the concerned region of the blood vessel. In theperformance of most open heart surgical procedures where occlusion ofthe ascending aorta is essential, however, the use of a vascular clampfor clamping this vessel creates a condition susceptible to seriousnegative consequences that the surgeon cannot completely control. Forexample, while the use of a vascular clamp to occlude the aorta providesa quick and easy occlusion of the vessel, clamping the aorta can disruptthe aortic wall, thereby dislodging degenerative plaque-like material,which is capable of migrating to the brain thereby resulting in astroke. Other consequences can also result from clamping the aorta. Forexample, the dislodged particles may migrate to other parts of the bodythereby creating the danger of limb gangrene in the extremities, such asthe arms or legs, or damage to certain organs as, for example, thekidney, the liver or the small or large bowel. Alternatively, inclamping the aorta, the wall may rupture thereby resulting inhemorrhage. Each of these complications can cause serious morbidity andoftentimes may result in death.

It is to the amelioration of these problems, therefore, to which thepresent invention is directed.

SUMMARY OF THE INVENTION

In accordance with a principle aspect of the present invention there isprovided an occluder apparatus for obstructing the flow of blood in ablood vessel comprising an elongated hollow tubular body having aleading end sized for reception in said blood vessel, means forinserting said body through the wall of said blood vessel to extend saidleading end into the interior of said blood vessel, an inflatablediaphragm carried in a collapsed, deflated condition within the interiorof said body, means for conducting an inflating fluid from an externalsource into fluid communication with the interior of said diaphragm toeffect expansion thereof, means in said body to enable release of saiddiaphragm in an inflated state from said body into flexible occludingengagement with the interior wall of said blood vessel aboutsubstantially the full circumference of a section thereof.

The invention contemplates use with the described occluder device of anexternal belt-like blood vessel wall-compressing device adapted tosurround the blood vessel and apply a compressive force in opposedrelation to the force applied by the occluder diaphragm. By use of thebelt-like compressing device the blood vessel can be effectivelyoccluded by the diaphragm without distention or distortion of the wallthereof thus to prevent flexure of the wall and dislodgement therefromof fragile material that could create a dangerous condition in thepatient.

Apparatus according to the invention can be particularly designed tofacilitate several procedures common to open-heart surgery. For example,besides obstructing the flow of blood to the heart to create a quiescentregion within which the surgeon can work, the apparatus can be designedto be useful in the introduction of myocardial preservation solution tothe proximal region of the aorta. On the other hand, the passagedesigned to conduct myocardial solution can, alternatively, be connectedto a pressure measuring device for monitoring aortic root pressure.Similarly, the passage can be employed for venting the aortic rootand/or clearing the heart and aortic root of blood and/or air.Importantly, the apparatus can also be made to perform as an aorticarterial perfusion cannula for circulating blood between a heart-lungmachine and the patient in bypass relation to the occluded region of theaorta and the heart.

It is, accordingly, an object of the invention to provide an improvedapparatus for occluding blood flow in blood vessels in selected bodysites, particularly in the ascending aorta, to facilitate surgicalprocedures.

It is another object of the invention to provide an effective bloodvessel occluder in which the danger of dislodging brittle material fromthe wall of the blood vessel and the concomitant danger of creatingserious morbidity is minimized.

Yet another object of the invention is to provide apparatus that permitsthe performance of multiple surgical functions and procedures through asingle incision made in the blood vessel thereby eliminating the need tomake plural incisions in the blood vessel commensurate with the numberof procedures to be performed.

For a better understanding of the invention, its operating advantagesand the specific objectives obtained by its use, reference is made tothe accompanying drawings and description which relate to preferredembodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective representation, partly schematic, of an occluderapparatus operatively associated with a pressurizing belt according tothe invention;

FIG. 2 is a perspective representation of the occluder apparatusaccording to the invention FIG. 2a is a view similar to FIG. 2,illustrating a structure to which the passage means may be connectedwhen the occluder apparatus is used with a source of myocardial fluid ora pressure monitor, or both; FIG. 2b is a partial sectional view of theoccluder apparatus of FIG. 2a, illustrating a structure to which thepassage means may be connected when the occluder apparatus is used witha heart-lung machine in a preliminary stage of installation;

FIG. 3 is a perspective representation of the occluder apparatusaccording to the invention in an intermediate stage of installation;

FIGS. 4 through 6 illustrate an embodiment of the invention in variousoperative stages when installed in a blood vessel.

FIG. 7 is a sectional view of the occluder apparatus and pressurizingbelt taken along line 7--7 of FIG. 6.

FIG. 8 is a sectional elevational view a trocar body carrying anoccluder diaphragm in its deflated condition;

FIG. 9 is a cross-sectional view taken along line 9--9 of FIG. 8;

FIG. 10 is a view of the diaphragm mounting plate with the diaphragmremoved;

FIG. 11 is a view illustrating the diaphragm in an inflated condition;

FIG. 12 is a plan view of a pressurizing belt according to theinvention;

FIG. 13 is a sectional view taken along line 13--13 of FIG. 12;

FIG. 14 is a view, similar to FIG. 1, illustrating another embodiment ofthe occluder apparatus and pressurizing belt according to the presentinvention;

FIG. 15 is a sectional view illustrating the occluder apparatus of FIG.14 in operative position within a blood vessel;

FIG. 16 is a partial sectional view taken perpendicularly of FIG. 15;

FIG. 17 is a sectional elevational view of a trocar body as shown inFIG. 14 carrying an occluder diaphragm in its deflated condition;

FIG. 18 is a sectional view taken along lines 18--18 of FIG. 17;

FIG. 19 is an elevational view of the trocar of FIG. 14 as viewed fromthe distal side;

FIG. 20 is an elevational view of the trocar as viewed from a lateralside;

FIG. 21 is an elevational view of the trocar as viewed from the proximalside;

FIGS. 22 and 23 are views similar to FIG. 21 illustrating the trocar ofFIG. 14 in various stages of installation;

FIG. 24 is a plan view of an alternate form of pressurizing beltaccording to the invention;

FIG. 25 is a sectional view taken along line 25--25 of FIG. 24; and

FIG. 26 is an elevational view of the pressurizing belt of FIG. 12 inoperative position on a blood vessel.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring particularly to FIG. 1 there is shown a blood vessel occluderapparatus, indicated generally at 10, comprising an elongated tubulartrocar 12 which is held in its operative position by pressurizing belt14 in a blood vessel 16, here shown as the ascending aorta connectingwith the heart muscle 18. The details of construction of the trocar 12are best shown in FIG. 8 as comprising an elongated, hollow, generallycylindrical tubular shell 20 formed of a relatively hard plasticmaterial, such as a polycarbonate material, that is open at both itsupper and lower ends, 22 and 24 respectively. The opening at the upperend 22 of the shell 20 is closed by a closure cap 26 having openingstherein to permit passage of fluid-conducting members, as hereinafterdescribed. The opening at the lower end 24 of shell 20 is of slightlysmaller diameter than that of the internal wall surface 28 of the shell,being defined by an inturned flange 30 forming a substantially annularshoulder 32 about the opening.

An annular flange 34 extends radially outwardly from the exteriorsurface of the shell 20 at an intermediate location along the lengththereof. The flange 34 is adapted to receive sutures 36 (FIG. 3) forfixedly attaching the trocar 12 in position on the wall of the bloodvessel.

Locking detents 38 formed of slightly compressible material are bondedto the shell surface and project radially outwardly from opposite sidesthereof at a level about midway between the flange 34 and the upper end22 of the shell. In the preferred embodiment of the invention, thesedetents 38 cooperate with locking means in the pressurizing belt 14, ashereinafter described, for establishing the positional relationshipbetween the trocar 12 and the belt 14 prior to operation of the occluderapparatus 10 according to the invention.

As shown in FIGS. 8 and 9 the interior of the tubular shell 20 formingthe trocar 12 is divided longitudinally by a partition plate 40 intotransversely spaced regions indicated by the numerals 42 and 44,respectively. The plate 40, as shown best in FIG. 9, extends chordallyacross the interior of shell 20 and has its opposite side edges sealedlyattached to internal wall surface 28. The lower end of partition plate40 is spaced upwardly from the lower end 24 of the shell 20 and attachesa closure plate 46 to define region 42 as a fluid conducting passage. Aflow opening 48, which may be an enlarged solitary opening in the wallof shell 20 or, as shown, formed of a plurality of small diameteropenings 49 extending therethrough, effects fluid communication betweenthe passage 42 and the exterior of the trocar 12. A line 50 extendsthrough the closure cap 26 and fluidly connects the other end of thepassage 42 to a fluid source, as for example a source of myocardialpreservation solution, on the exterior of the trocar. See FIG. 2a.

In the described apparatus, the passage 42 can, during alternate periodsof operation, be employed to establish fluid communication between theinterior of the blood vessel 16 and a pressure monitor (not shown) viathe opening 48 and a flow line 51 that, at one end, extends through thecap 26 to communicate with the passage 42 and, at the other end,connects with the pressure monitor. See FIG. 2a.

A second chordally extending plate 52 extends across the interior of theshell 20 parallel to, but slightly spaced from, the plate 40. The plate52 contains a plurality of small diameter through-openings 53, typicalexamples of which are shown in FIGS. 10 and 11, and on its surfacefacing the interior region 44 of the trocar body 12 mounts an expandableoccluder diaphragm 54 formed of thin walled, flexible material, such aspolyeurathane. The space between plates 40 and 52 contains a pair ofconductors 56 extending downwardly from a manifold 58 that mounts afluid-conducting tube 60 for conducting saline activating fluid to theinterior of the diaphragm 54 for inflating and expanding it into itsoperative condition. Flow distribution between the openings 53 inpartition plate 52 and respective regions of the diaphragm 54 iseffected by small diameter passages 55 that extend between the openings53 and similar openings 57 in the diaphragm wall.

In its expanded condition the diaphragm 54 assumes a shape correspondingessentially to that illustrated in FIGS. 6, 7 and 11 comprising agenerally toroidally-shaped cushion portion 62 and a membrane portion 64that fills the region of the diaphragm interiorly of the cushionportion. Upon inflation with saline fluid the diaphragm 54 is permittedto expand exteriorly of the trocar 12 by means of a pair of aligned,oppositely spaced slots 66 that extend upwardly from the open lower endof the shell 20. The slots 66 are so positioned in the shell 20 withrespect to the diaphragm 54 in its deflated condition to enable it toreadily project laterally outwardly into engagement with the interiorwall 68 of the blood vessel 16. Thus, when expanded, the diaphragm 54effectively occludes flow through the blood vessel 16 with the opening48 in shell 20 being disposed in facing relation to the proximal side ofthe apparatus.

The apparatus 10 contains an expandable penetrating plug 70 that, whenexpanded, is conical in shape. The base 72 of plug 70 has a peripheraldiameter permitting its engagement with the shoulder 32 formed at thelower end of shell 20. The apex 74 of the plug 70 extends axiallyoutwardly from the open lower end 24 of the trocar body 12 to form apointed tip suitable for penetrating the wall of the blood vessel 16 topermit insertion therein of the lower portion of the trocar after anincision has been made in the blood vessel wall.

The plug 70 is hollow and has walls formed of an expandable flexiblematerial, such as polyeurathane. A substantially rigid, elongated tube76 attaches at its lower end to the base 72 of the plug 70 with thepassage through the tube in fluid communication with the hollow interiorof the plug. The upper end of the tube 76 extends through a self-sealingopening in the cap 26 to connect with an exterior source of salinefluid.

In practice, the trocar 12 is inserted radially through the wall of theblood vessel 16 by the surgeon's first making an incision 80 (FIG. 2)therein of an extent sufficient to permit insertion of the shell 20. Theincision will be of such extent as to create an opening in the bloodvessel wall of such an extent as to cause the shell 20 to be snuglyreceived therein. (In preparation for closing the opening formed by theincisions 80, the surgeon may install a purse-string suture 81 about theopening). Thereafter, assisted by the piercing tip formed by theexpanded plug 70, the trocar is caused to penetrate the blood vesselunder the impetus of a downwardly-directed manual force applied to thetrocar 12. The extent of insertion of the trocar into the interior ofthe blood vessel 16 is limited by the flange 34 which, when placed inengagement with the exterior surface of the wall of the blood vessel,will locate the tip 74 of the plug at, or closely spaced from, the bloodvessel wall opposite the incision 80.

Next, by properly aligning the trocar with the longitudinal axis of theblood vessel 16, as by means of guide marks (not shown) on the surfaceof the flange 34, proper disposition of the trocar can be determinedsuch that the elongated slots 66 are aligned transversely across theblood vessel section. Sutures 36 are then applied via openings 35 formedin the flange 34 to securely attach the flange to the wall of the bloodvessel 16.

Following this step, the fluid employed to expand the plug 70 isreleased therefrom by venting the fluid through the tube 76. Uponcollapse of the plug walls, the tube 76 is withdrawn through aself-sealing opening in the cap 26 that accommodates passage of thecollapsed plug.

With the trocar 12 thus installed in the blood vessel 16 the more basicfunctions contemplated for the occluder apparatus 10 can be achieved.For example, when inflating fluid, such as saline liquid, is admitted atpressures controlled by a valve (not shown) provided in the line 60, thefluid flows into manifold 58 and through the conductors 56 and theopenings 53 in the partition plate 52 into the collapsed diaphragm 54,inflation will occur whereby the diaphragm will be caused to expand,with expansion beyond the confines of the shell 20 being permitted bymeans of the laterally facing openings therein created by the elongatedslots 66. In expanding, the outer peripheral edge of thetoroidally-shaped cushion portion 62 of the diaphragm 54 is, as bestshown in FIGS. 6 and 7, caused to engage the inner wall surface 68 ofthe blood vessel 16 about substantially the entire circumferencethereof. The material of which the diaphragm is constructed being ofthin, light weight construction, and the pressure of the inflating fluidbeing appropriately controlled, the cushion portion 62 of the diaphragmis caused to closely envelop the shell body while conforming to theblood vessel wall tissue surface configuration so that an effectiveblood flow-occluding obstruction is effected in the blood vessel 16without significant distention or description of the blood vesel wall.

Where the described apparatus 10 is employed for aortic occlusion, withthe patient effectively connected to a heart-lung machine in a mannerwell known in the surgical arts, it will be appreciated that, as well asproviding the surgeon with a quiet, bloodless field on the proximal sideof the occlusion within which to operate, the apparatus permits thepractice of other procedures, as well. See FIG. 2b. For example, withline 50 connected to a source of myocardial preservation solution orblood cardioplegia, by periodic operation of a control valve (not shown)this solution can be supplied intermittently through passage 42 andexiting the trocar through the holes 49 forming opening 48 to the rootof the aorta for perfusion through the coronary arteries into the heartmuscle 18 to preserve and arrest the heart, thereby to facilitate theperformance of a surgical procedure.

Also, during periods in which the line 50 is not employed for the supplyof myocardial preservation fluid, it can be conveniently employed, bymeans of a suitable bypass connection containing valving to anevacuation pump (not shown), for removing blood from the heart via theaorta root thereby preventing the accumulation of blood in the heart andmaintaining the heart in a collapsed condition whereby the practice of asurgical procedure on the heart can be facilitated.

Furthermore, the bypass connection attached by way of line 50 toapparatus 10 can also be employed, during the occlusion period orfollowing completion of the surgical procedure on the heart anddeflation of the occluder, for the evacuation of any air bubbles fromthe heart chambers and the ascending aorta.

Still further, with the opening 48 in the trocar shell wall 20positioned closely adjacent the wall surface 68 in the upper region ofthe aorta passage, the line 50 can be effectively employed as a vent forremoving air bubbles in the blood as it is pumped into the ascendingaorta from the heart upon collapse of the occluder diaphragm 54 whenexpansion fluid is released from the line 60 and the heart resumes itscontraction. Use of the occluder apparatus 10 for this purpose is mostadvantageous because the protrusion of the trocar into the aorta willcreate turbulence in the blood flow and the presence of the collapseddiaphragm 54 in the blood flow passage will tend to partially obstructand retard the blood flow in this region and the entrained air bubbleswill migrate upwardly whereby there evacuation through the opening 48 isenhanced.

Notwithstanding the capability of utility of the apparatus 10 in theabove described manner, in its preferred mode of operation, theapparatus will be used in association with a pressurizing belt 14, thedetails of construction of the embodiment of FIG. 1 of which are bestillustrated in FIGS. 12 and 13 herein. Accordingly, the belt 14comprises a base 86 containing an upstanding collar 88 having athrough-opening 90 that permits passage of the trocar 12. The base 86 isgenerally C-shaped and defines wings 92 on opposite sides of the collar88 to form a strap-like structure. Openings 93 adjacent the terminalends of the wings 92 are adapted to receive sutures for securing thewings to the blood vessel. The base 86 is formed of a plastic material,such as a polycarbonate material, having sufficient rigidity to impartstrength to the construction, yet being sufficiently flexible to permitthe wings 92 to flex, thereby enabling them to enclose the blood vessel16 without distortion thereof, upon manual manipulation of operatingtabs 94 that are integrally formed on or bonded to the respective wings.The undersurface of the base 86 which, in operation, faces the exteriorof the blood vessel 16 has attached thereto by means of bonding, or thelike, an inflatable cuff 96 formed of soft, pliable material. Aninflating fluid inlet 98 is formed on one of the wings 92 and contains apassage that communicates with the interior of the cuff 96 whereby aninflating fluid can be supplied or released in order to expand orretract the cuff into and out of compressing relation with the enclosedblood vessel 16.

As shown, the opening 90 in collar 88 is formed along its wall withopposed channels 100, at the top of both of which is formed a cup-shapedrecess 102. These structural elements cooperate with the detents 38 onthe external surface of the trocar shell 20 to positionally fix thetrocar 12 with respect to the belt 14 and thereby establish thetransverse disposition of the slots 66 in the shell with respect to theblood vessel section.

In the described embodiment of the invention, after the trocar 12 issutured to the blood vessel 16, the pressurizing bolt 14 is mountedthereon with the collar 88 telescopically received on the upper portionof the trocar shell 20 that projects from the blood vessel wall. As thecollar 88 is slid into position the opposed detents 38, which are ofcompressible material, slidingly engage the channels 100 where they arecompressed. Upon reaching the cup-shaped recesses 102 the detents 38expand into the recesses to lockingly set the positional relationshipbetween the trocar 12, the pressurizing belt 14 and the blood vessel 16.

Importantly, as best shown in FIG. 6, upon completion of the assembly ofthe pressurizing belt 14 and the trocar 12, the cuff 96 on the belt isdisposed on the opposite side of the wall of blood vessel 16 from theoccluder cushion 62. In the preferred practice of the invention, theline 60 that supplies saline liquid for expanding the diaphragm 54 isconnected in parallel with the inlet 98 to the cuff 96 on thepressurizing belt 14. Thus, the expansion fluid is admittedsimultaneously to both the occluder diaphragm 54 and to the cuff 96 sothat occlusion of the blood vessel flow passage is accomplished withoutdanger of either compression or distention of the wall thereof.Moreover, because the material that forms both the cushion 62 of thediaphragm 54 and the cuff 96 on the belt 14 is soft and pliable andthereby readily conformable to the blood vessel wall structure, it willbe appreciated that upon expansion of these members occlusion isaccomplished without danger of dislodging fragile material or brittletissue from the wall of the blood vessel or of squeezing atheroscleroticmaterial into the vessel passage.

FIGS. 14 to 23 illustrate another trocar organization 12' which isconstructed according to the invention and FIGS. 24 to 26 illustrate analternate form of pressurizing belt 14' employing a collar 88' which isparticularly adapted for use with the trocar organization of FIGS. 12 to23 but whose base portion 86' can be used interchangeably with that ofthe belt 14.

With reference to FIG. 14, which is a view similar to FIG. 1, there isillustrated a modified form of trocar 12' operably assembled with themodified form of pressurizing belt 14' and applied to an ascending aorta16 connected with heart muscle 18. In the practice of this form of theinvention, the pressurizing belt 14' is first applied to the walls ofthe blood vessel 16 and thereafter the trocar 12', equipped with scalpelblades 146 (FIG. 17), as hereinafter described, incises the wall of theblood vessel 16 as the trocar is extended into the belt collar 88'. Theconstruction of the trocar 12', moreover, is such as to permit, besidesthe functions described for the embodiment of FIGS. 1 to 11, theadditional functions of operation of an aortic arterial perfusioncannula for circulation of blood between the patient and a heart-lungmachine, with all such functions being achieved form a single incisionmade in the aorta wall upon application of the trocar into the collar88' of the pressurizing belt 14'.

Accordingly, as best shown in FIG. 17, the trocar 12' comprises agenerally tubular shell 20', the wall of which is formed intermediateits upper and lower ends with an annular shoulder 106 that divides theshell into a larger diameter upper portion 108 and a reduced diameterlower portion 110. Shoulder 106 operates to limit the extent ofpenetration of the trocar into the aorta passage.

The upper end of the shell 20' is closed by a closure cap 26' having asingle opening formed with self-sealing capability to permit passage ofa blade assembly 144 along the shell axis and retractive withdrawal ofthe blade assembly at an appropriate point in the operational procedureof the apparatus, as hereinafter described. As shown, the trocar shell20' is provided in the lower portion 110 with laterally alignedelongated slots 66' extending upwardly from the lower end of the shellto permit egress of the occluder diaphragm 54 upon application of theinflating fluid thereto.

The lower portion 110 of the shell 20' is provided on one side of theslots 66' with a discharge opening 48', here shown as a plurality ofsmall diameter holes 49', for communicating an internal passage 42'formed by a chordally disposed plate 116 and a cover plate 118 with theproximal side of the trocar 12'. The passage 42' contains two sources ofcommunication with the exterior. The first, comprising an inletconnection 119 in the shell wall and an abbreviated fluid line or elbow120 that fluidly connects the connection 119 with the interior of thepassage 42', serves to supply myocardial preservation solution to theaorta, in a manner as previously described, when the trocar is operablyinstalled in the aorta. By means of a second fluid connection 122communicating with the passage 42' the trocar can also be connected to apressure monitor device (not shown) by means of which, and throughappropriate manipulation of the respective valves 124 and 126 in thelines attaching with the connectors 119 and 122, the passage 42' can beutilized alternately as a means for supplying myocardial preservationsolution and as a means for detecting the pressure in the aorta betweenthe intervals during which the myocardial preservation solution issupplied and before or after the occluder is distended to measure theblood pressure in the ascending aorta.

As in the previous embodiment, the occluder diaphragm 54 is attached toa second chordally extending plate, here indicated as 52', that isspaced from the first plate 116. The diaphragm 54 communicates with asource of saline inflating liquid via inlet connection 128 that isconnected to a manifold 58' via the internal conductor 130 withconductors 56' interconnecting the manifold with openings 53' formed inthe plate 52'. Similar to the previously described apparatus, theinflating fluid supply line connecting with the manifold 58' isdesirably made common with the inlet connector 98 to the belt cuff 96 inorder that inflating fluid is delivered substantially simultaneously toboth the diaphragm 54 and to the belt cuff in order to insure anequalization of the compression applied to the opposed surfaces of theblood vessel wall.

The interior region 132 of the trocar shell 20', exteriorly of thepassages 42' and 56' formed by the partition plates 52 and 116, definesa passage included in the blood circulating line between the patient anda heart-lung machine (not shown). To render such circulating floweffective, the trocar shell 20' is provided in the lower portion 110 onthe side of the slots 66' opposite that containing the opening 48' withan elongated opening 134 that is sufficiently sized to accommodate bloodflow from the heart-lung machine and return to the ascending aorta onthe distal side of the expanded occluder diaphragm 54, as hereinaftermore fully described. Connection from the heart-lung machine to the endof the trocar upper portion 108 is made by means of a tubular feed line136 (FIG. 14) that is fixedly attached to the shell by means ofconnecting elements 138 of well-known type on the exterior surface ofthe shell 20' which cooperate with complimentary elements in the line. Avalve mechanism 140 operated by actuating knob 142 is effective to openand close the flow circulating line as further explained herein.

Extending axially of the shell 20' is the blade assembly, indicatedgenerally by reference numeral 144. It includes a plurality ofarticulated scalpel blades 146, here shown as being three in numberdisposed on 120° angular spacing but which may comprise a greater orlesser number of blades. The blades 146 are arranged to be retractablyextended from the opening 27' at the tip of the lower portion 110 ofshell 20' whereby, when the trocar 12' is inserted by the surgeonlongitudinally into the belt collar 88', the blades are effective toincise the wall of the aorta to permit penetration thereof by the lowerportion 110 of the trocar apparatus.

The blade assembly 144 comprises an axially disposed support rod 148, tothe leading end of which each of the blades is attached by a pivotconnection 150 thereby forming a sharp point. At its upper end the bladesupport rod 148 contains an operating head 152 and a spacer flange 154axially spaced therefrom. Support rod 148 is concentrically received inan axially elongated support sheath 156 for relative sliding movementsthere-between. Articulating links 158 connect the rear ends of therespective blades 146 to the leading end of sheath 156 by means of pivotconnections 160. An operating flange 162 at the rear end of the sheath156 effects movement of the sheath with respect to the support rod 148whereby extension of the sheath downwardly causes the respective blades146 to be angularly displaced outwardly into engagement with theshoulder 32' formed by the inturned flange 30' that defines the opening27' at the lower end of the shell 20'.

The sheath 156 is concentrically enclosed by an elongated carrier sleeve164 having an operating flange 166 at its rear end. The leading end ofthe carrier sleeve 164 contains a plurality of circumferentially spacedcontainment slots 168 adapted to receive the respective articulatedlinks 158 and blades 146 when the sheath 156 is retracted into thecarrier sleeve prior to withdrawal of the blade assembly 144 from thetrocar 12'.

In order to properly position the elements of the blade assembly 144prior to inserting the trocar 12' into the belt collar 88' the apparatusincludes an applicator cover 170, here shown as being a cylindricalshell having a closure plate 172 at the top and an interior integratedstepped sleeve 174 having lands 176 and 178 adapted to engage theoperating flanges 162 and 166 on the rear ends of the sheath 156 andcarrier sleeve 164, respectively. The undersurface of the closure plate172, as shown, provides the bearing surface for the operating flange 152on the support rod 148.

The lower end of the applicator cover 170 is arranged to seatedly engagethe upper surface 182 of a hollow cylindrical spacer 180. As shown, theopposed upper and lower surfaces 182 and 184, respectively, of thespacer 180 contain aligned axial openings 186 and 188 to accommodatepassage of the blade assembly 144. The lower surface 184 of the spacer180 engages the facing surface of the closure cap 26' to create asubstantially rigid structure extending the full length of the assembledtrocar apparatus.

The pressurizing belt 14' adapted for use with this embodiment of theapparatus is particularly illustrated in FIGS. 24 to 26. It comprises abase structure 86' having an upstanding collar 88', the lattercontaining a through-opening 90' for reception and passage of the trocar12'. The base structure 86' is adapted to completely surround the aorticblood vessel 14 and for this reason contains a hinge 190 on one side ofthe collar 88' that divides the base into two wings, one of which 192contains the collar and inflating fluid connector 98' and the other 194of which has a locking detent 196 formed at its end for engagement witha cooperating notch 198 in the end of wing 192. As in thepreviously-defined belt structure 14 the undersurface of the base 86'attaches an expandable cuff 96', the interior of which fluidly connectsvia connector 98' with a source of inflating fluid (not shown).

The collar 88' differs from that in the previous embodiment ofpressurizing belt 14 in that the through-opening 90' is formed toaccommodate downward reception of the trocar 12'. This opening 90' isalso provided with a locking device, here shown as a bayonet-typeconnection 200, defined by opposed grooves 202 formed in the wall of theopening. Each groove 202 has an open upper end at 204 in the wall of thecollar opening 90' and a seat 206 at the lower end thereof, whereby apair of diametrally opposed projections 208 on the exterior surface ofthe upper portion 108 of trocar 12' are caused to traverse the groovesas the trocar is projected into the belt collar 88' causing the trocarto undergo approximately 90° rotation about its longitudinal axis forultimate seating in the seats 206 to effectively lock the trocar 12'with respect to the belt collar.

As shown in FIGS. 19 through 23, the projections 208 are positioneddiametrally on the external surface of the shell 20', with each beingdisposed in substantial alignment with the openings 48 and 134,respectively. Thus, with the projections 208 lockingly received in therespective bayonet seats 206, the slots 66' are positioned transverselyof the blood vessel passage in order to render the diaphragm 54', whenactivated, effective to occlude flow through the passage.

The operation of this embodiment of the invention is as follows.Following incision of the chest cavity by the surgeon to expose theascending aorta 16 and heart muscle 18 and selection of the positionalong the aorta at which occlusion of the blood vessel will be effected,the pressurizing belt 14' is mounted to the blood vessel 16 by firstspreading the wings 192 and 194 by means of hinge 190 to permitreception of the belt around the blood vessel without distortion thereofand, thereafter, insertion of the detent 196 into the slot 198 to lockthe belt in surrounding relation to the aorta.

Next, the trocar 12', with the valve 140 actuated to its open positionand with the blade assembly 144, applicator cover 170 and spacer 180 inposition is inserted into the opening 90' of the collar 88' of thepressurizing belt 14' by registering the projections 208 on the exteriorof the trocar shell 20' with the open ends 204 of the slots 202 of thebayonet connection 200. As the projections 208 move along the verticalportions of the respective slots 202, the blades 146 incise the wall ofthe aorta whereby the trocar 12' is caused to penetrate into theinterior of the aortic passage. The length of the lower portion 110 ofthe shell 20' is such that, when the shoulder 106 engages the aortaouter wall the tips of the blades 146 are slightly spaced from the aortainner wall on the side opposite the incision. This spacing of the tipsof blades 146 from the opposite side of the aorta wall is furthercontrolled by the cooperation between the projections 208 and thebayonet seats 206 that prevents excessive penetration by the lower endof the trocar into the interior of the aorta.

Also, because the blades 146 produce a cut in the aorta wall of slightlysmaller lateral extent than the outside diameter of the lower portion110 of the shell 20, a snug fit between the trocar 12 and the aorta wallis created and because closure cap 26 contains a self-sealing septumseal through which the blade assembly 144 passes, blood flow through thetrocar from the incised opening in the aorta wall is contained.

Following this, the applicator cover 170 is removed, as shown in FIG.22, to expose the rear end of the blade assembly 144, particularly theoperating heads 152, 162 and 166 of the blade support red 148, sheath156 and carrier sleeve 164, respectively. With the support red head 152being held against retrograde movement, the head 162 on sheath 156 ispulled upwardly to angularly constrict the blades 146. When the head 162abuts the spacer flange 154 on the support red 148 the blades 146 havebeen completely constricted and moved into the containment slots 168 inthe carrier sleeve 164. Next, the carrier sleeve 164 is withdrawn fromthe trocar 12' by pulling on the head 166 thereof.

An indicating mark (not shown) is provided on the exterior of thecarrier sleeve 164 and so positioned thereon as to indicate, when itappears immediately above the spacer 180, that the lower end of theblade assembly 144 is above the valve 140. At this instant the valveoperator knob 142 is rotated to close the valve and, thereafter, thespacer 180 and closure cap 26' may be removed from the upper end of thetrocar 12'.

When the upper end of the trocar is effectively open upon removal of cap26', the valve 140 may be opened briefly in order to back bleed theaorta and expel any air that may be entrained in the trocar. Upon againclosing the valve 140 the flow line 136 from the heart-lung machine isattached to the trocar by making the connection with the connectingelements 138.

Once the heart-lung machine is functional, blood is circulated throughthe flow line 136 and trocar internal passage 132 for discharge from thetrocar through the opening 134 on the distal side of the shell.Thereafter, inflating fluid in the form of pressurized saline liquid isadmitted simultaneously to the pressurizing belt cuff 96' and to theoccluder diaphragm 54 by actuation of control valve 129. The flow ofinflating liquid through the trocar 12' occurs in series through theinlet connection 128, internal conductor 130, manifold 58', conductors56' and openings 53 into the interior of the diaphragm 54. Uponinflating, the diaphragm 54 expands laterally, exiting the trocarthrough the slots 66' whereupon it enters the aortic passage 16 andexpands such that the toroidal cushion 62 is brought into occludingengagement with the interior surface of the passage wall. Simultaneousadmission of saline liquid to the cuff 96' applies an equal pressureforce to the external wall of the aorta in opposition to the forceapplied by the toroidal cushion 62 of the occluder diaphragm 54 wherebythe aortic wall is acted upon by balanced forces to prevent itsdistention or collapse under the influence of the occluder diaphragm orbelt cuff. In practice due to the relative flow areas presented to theinflating liquid by the trocar 12' and pressurizing belt 14',respectively, the belt cuff 96' will desirably become pressurizedslightly prior in point of time from pressurization of the occluderdiaphragm 54.

It will be appreciated that, by so-maintaining the aortic wall, thepassage can be effectively occluded without disrupting the wall andwithout creating the attendant danger of its rupturing or of dislodgingmaterial therefrom which could cause serious morbidity or even death tothe patient. In occluding the aortic passage its proximal side isrendered quiet and bloodless where the surgery can be performed safely.

Following completion of the surgical procedures requiring occlusion ofthe aortic passage the diaphragm 54 and cuff 96' are deflatedsimultaneously by the release of the inflating saline liquid from theinteriors of these members by opening valve 129. Desirably a negativepressure may be applied in the fluid line communicating with themanifold 58', conductors 56' and diaphragm interior whereupon thediaphragm is positively induced to collapse so that the trocar 12' canbe efficaciously removed from the aorta.

Practice of the invention, furthermore, permits, via a single incisionmade in the aortic wall, a multitude of ancillary procedures to beperformed. For example, by operation of control valve 124 myocardialpreservation solution can be periodically admitted to the root of theaorta 16 to arrest and preserve the heart muscle 18 thus to render itmore quiet and motionless so that cardiac surgery can be performed moreeffectively. As will be appreciated from consideration of FIG. 17, thisis accomplished by the opening of control valve 124 whereby myocardialpreservation liquid enters the trocar 12' through inlet connection 118and flows seriatim through the elbow 120 and passage 42' before exitingthe trocar to the proximal side thereof via the discharge opening 48'.

Also, by provision of a fluid line 121 containing control valve 126communicating with passage 42' via connection 122 and extending to apressure gauging device (not shown), the pressure in the aorta can beeffectively monitored during application of myocardial preservationsolution to permit determination of proper and complete distribution ofthe solution throughout the coronary tree. In addition, when thediaphragm 54 is deflated, this fluid line can be employed to monitorstandard systematic pressure.

The fluid passage 42' and opening 48' in the shell wall are furtheroperable for the extraction of fluid from the aorta root and the heart.For example, during the period of aortic occlusion, and when themyocardial preservation solution system is inactive, in order to keepthe ascending aorta and heart collapsed and free of blood, a negativepressure can be applied to the passage 42' by appropriate connection ofthe line 119 to a negative pressure source and the system employed forthe removal of blood from the heart and from the aorta root.

Similarly, this same fluid conducting system can also be employed as ameans for venting air from the heart and the ascending aorta followingcompletion of the surgical procedure on the heart when the occludingdiaphragm 54 has been collapsed so as to remove the flow obstructionfrom the aortic passage. During this period, when the patient remains onthe heart-lung machine and before the blood-ejecting function isreturned to the heart, it is necessary to insure that all air bubblesare removed from the heart chambers. This is commonly achieved throughuse of a vent placed in the left atrium or left ventricle. Upon clampingof this vent to permit filling of the left ventricle and ejection ofblood by the heart into the ascending aorta, it is desirable, as anadded precaution, to vent an amount of blood from the ascending aorta toinsure the evacuation of any micro air bubbles entrained in the bloodbefore they can be dispersed into the cerebral circulation thereby toprevent the danger of possible stroke.

Use of the trocar 12' for the performance of this function isparticularly advantageous due in part to the disposition of the opening48' closely adjacent the upper portion of the aortic wall whereby aircan readily migrate into the opening for extraction via passage 42' andthe line from connector 119 that, during occlusion of the aorta is usedto conduct myocardial solution. Importantly, air extraction in themanner described is enhanced by the protrusion of the trocar 12' intothe aorta passage whereby turbulence in the blood flow stream iscreated. Also, the presence of the deflated diaphragm 54 in the aorticpassage creates a restriction tending to retard blood flow and therebyfacilitate air removal by enhancing the ability of the air bubbles tomigrate to the upper region of the blood flow stream from whence theycan be extracted by induction through the opening 48'.

It should be understood that, although preferred embodiments of theinvention have been illustrated and described herein, changes andmodifications can be made in the described arrangements withoutdeparting from the scope of the claims appended hereto.

I claim:
 1. An occluder apparatus for obstructing the flow of blood in ablood vessel comprising, in combination:an inflatable diaphragm carriedby a diaphragm insertion body in a deflated condition into the interiorof said blood vessel for expansion under the influence of fluid pressureinto engagement with the interior wall of said blood vessel aboutsubstantially the full circumference thereof; a belt-like pressurizingdevice adapted to receive said body comprising an inflatable cuffarranged to substantially surround the exterior of said blood vessel,said cuff being expandable under the influence of fluid pressure intoengagement with the exterior wall of said blood vessel in substantiallyopposing relation to said diaphragm when expanded; means for inflatingsaid diaphragm; and means for inflating said cuff.
 2. The combinationaccording to claim 1 in which said diaphragm-inflating means and saidcuff-inflating means are fluidly interconnected for the substantiallysimultaneous admission of pressurizing fluid to said diaphragm and saidcuff.
 3. The combination according to claim 1 in which said belt-likepressurizing device comprises a base adapted to enclose the exterior ofsaid blood vessel; means for attaching said cuff to said base; andinflating fluid inlet means formed on said base and connecting with saidcuff to supply the interior thereof with pressurizing fluid.
 4. Anoccluder apparatus for obstructing the flow of blood in a blood vesselcomprising, in combination:an elongated hollow tubular body having aleading end for reception in said blood vessel; means for inserting saidbody through the wall of said blood vessel to extend said leading endinto the interior of said blood vessel; an inflatable diaphragm carriedby said body in a collapsed, deflated condition for insertion into theinterior of said blood vessel; means for inflating said diaphragm toexpand it about its periphery into cushioned occluding engagement withthe interior wall of said blood vessel; a belt-like pressurizing deviceincluding an inflatable cuff arranged to substantially surround theexterior of said blood vessel and to be expanded under the influence offluid pressure into engagement with the exterior wall thereof insubstantially opposing relation to the engagement of said interior wallof said blood vessel by said diaphragm; and means for inflating saidcuff.
 5. The combination according to claim 4 in which saiddiaphragm-inflating means and said cuff-inflating means are fluidlyinterconnected for the admission of pressurizing fluid for thesubstantial simultaneous inflating of said diaphragm and said cuff. 6.The combination according to claim 5 in which said belt-likepressurizing device comprises:a base adapted to enclose the exterior ofsaid blood vessel; means for attaching said cuff to the wall-facingsurface of said base; inflating-fluid inlet means formed on said base influid communication with the interior of said cuff for supplyingpressurizing fluid thereto; and means on said base retaining saidtubular body.
 7. The combination according to claim 6 in which saidretaining means comprises a substantially annular collar extending fromthe exterior surface of said base; and means forming an openingextending through said collar and said cuff to receive said tubularbody.
 8. The combination according to claim 7 including at least onelocking projection extending from said tubular body; and means on saidcollar cooperable with said projection for fixedly retaining saidtubular body.
 9. The combination according to claim 8 including means onthe exterior of said tubular body for receiving sutures to fix said bodyto said blood vessel; and said locking projection on said tubular bodyengaging a cooperating recess in said collar when said belt issuperimposed on said body.
 10. The combination according to claim 8including a bayonet slot formed on the interior surface of said collar,said bayonet slot cooperating with said locking projection upon applyingsaid tubular body to said collar for locking said tubular body withrespect to said collar.
 11. The combination according to claim 8including piercing means disposed at the leading end of said tubularbody for incising the wall of said blood vessel upon extending saidtubular body through said collar.
 12. The occluder apparatus accordingto claim 4 in which said diaphragm release-enabling means compriseselongated opening means extending longitudinally of said body.
 13. Theoccluder apparatus according to claim 12 including means forming apartition extending transversely of the interior of said body defininglongitudinal fluid-conducting passage means therein; and means formingfluid openings in the wall of said body to place said passage means influid communication with the exterior of said body.
 14. The occluderapparatus according to claim 13 in which said fluid passage meansincludes means at an end opposite said wall openings connecting saidpassage means with at least one fluid source exteriorly of said body.15. The occluder apparatus according to claim 14 in which said passagemeans connects at said end with a heart-lung machine for circulatingblood to said blood vessel on a side of said diaphragm.
 16. The occluderapparatus according to claim 15 including valve means in said passagemeans for selectively admitting blood supply from heart-lung machine tosaid passage means.
 17. The occluder apparatus according to claim 15 inwhich said partition means comprises a partition plate extendingchordally across the interior of said tubular body to divide saidinterior into parallel longitudinally-extending fluid-conductingpassages; first opening-forming means in the wall of said body on oneside of said diaphragm release-enabling means for fluidly communicatingone of said passages with said blood vessel on the proximal side of saiddiaphragm and second opening-forming means in the wall of said body onthe other side of said diaphragm release-enabling means for fluidlyconnecting the other of said passages with said blood vessel on thedistal side of said diaphragm.
 18. The occluder apparatus according toclaim 17 including means at an end of said one passage for connectingsaid one passage to a source of myocardial fluid and to a pressuremonitor, and valve means operable with said connecting means forconnecting said passage to said source of myocardial fluid and to saidpressure monitor.
 19. The occluder apparatus according to claim 18including means at an end of said other passage for connecting saidother passage to a heart-lung machine; and vlave means in said otherpassage for selectively circulating blood from said heart-lunch machineto said blood vessel on the distal side of said diaphragm.
 20. Theoccluder apparatus according to claim 17 means at an end of said otherpassage for connecting said other passage to a heart-lung machine tocircular blood from said heart-lung machine to said blood vessel on thedistal side of said diaphragm.
 21. The occluder apparatus according toclaim 20 valve means in said other passage for selectively circulatingblood from said heart-lung machine to said blood vessel on the distalside of said diaphragm.